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Elacestrant

Elacestrant is an emerging drug being studied in clinical trials for the treatment of advanced breast cancer, particularly in patients with estrogen receptor-positive (ER+) and HER2-negative tumors. This article explores the ongoing research and potential benefits of Elacestrant in various clinical settings, including its use as a single agent and in combination with other therapies.

Table of Contents

What is Elacestrant?

Elacestrant is a new medication being studied for the treatment of certain types of breast cancer. It is also known by other names such as RAD1901, ER-306323, and Orserdu[1]. This drug is part of a class of medications called selective estrogen receptor degraders (SERDs), which work by targeting and breaking down estrogen receptors in cancer cells[2].

How Elacestrant Works

Elacestrant works by specifically targeting and breaking down estrogen receptors in breast cancer cells. Estrogen receptors are proteins found on some breast cancer cells that, when activated by estrogen, can promote cancer growth. By degrading these receptors, elacestrant helps to slow down or stop the growth of estrogen-dependent breast cancer cells[2].

Conditions Treated by Elacestrant

Elacestrant is primarily being studied for the treatment of:

  • Advanced or metastatic breast cancer: This refers to breast cancer that has spread beyond the breast to other parts of the body[3].
  • Estrogen receptor-positive (ER+) breast cancer: This type of breast cancer has cells with estrogen receptors on their surface[3].
  • HER2-negative breast cancer: This means the cancer cells do not have high levels of a protein called HER2 on their surface[3].
  • Breast cancer with ESR1 mutations: ESR1 is a gene that can mutate in some breast cancers, potentially making them resistant to certain treatments[4].
Elacestrant is being studied in both women and men with these types of breast cancer[3].

Clinical Trials and Research

Several clinical trials are currently underway to evaluate the effectiveness and safety of elacestrant:

  • ELCIN study: This trial is looking at elacestrant in patients who haven’t previously received certain types of breast cancer treatments[3].
  • ELIPSE study: This is a short-term study examining how elacestrant affects breast cancer cells before surgery[5].
  • Safety studies: Some trials are specifically looking at the safety of elacestrant in different patient groups, including those with liver problems[6].
  • Combination therapy studies: Researchers are also investigating how elacestrant works when combined with other cancer drugs[7].
These trials aim to determine how well elacestrant works, what dose is best, and what side effects it might cause.

Dosage and Administration

Elacestrant is typically taken as an oral tablet. The dosage being studied in most trials ranges from 300 mg to 400 mg once daily[5]. However, the exact dosage may vary depending on the specific study or patient factors. It’s important to note that the optimal dose is still being determined through clinical trials.

Potential Side Effects

As with any medication, elacestrant may cause side effects. While the full range of potential side effects is still being studied, some trials are specifically looking at:

  • General adverse events (unwanted side effects)
  • Serious adverse events (side effects that may require medical attention)
  • Changes in laboratory test results
  • Changes in vital signs
  • Changes in heart rhythm (as measured by ECG)[7]
It’s important to remember that not all patients will experience side effects, and the severity can vary from person to person. Always discuss potential side effects with your healthcare provider.

Combination Therapies

Researchers are exploring how elacestrant works when combined with other cancer treatments. Some combinations being studied include:

  • Elacestrant with abemaciclib: This combination is being studied for breast cancer that has spread to the brain[1].
  • Elacestrant with onapristone: This combination is being tested in patients with advanced or metastatic breast cancer[7].
  • Elacestrant with triptorelin: This combination is being studied in premenopausal women with breast cancer[8].
These combination therapies aim to improve treatment effectiveness by targeting cancer cells in multiple ways.

Future Research and Potential Applications

Ongoing research is exploring new ways to use elacestrant, including:

  • Treatment for early-stage breast cancer before surgery[5]
  • Use in premenopausal women with breast cancer[8]
  • Combination with newer experimental drugs[9]
These studies aim to expand the potential uses of elacestrant and improve outcomes for more breast cancer patients.

Aspect Details
Drug Name Elacestrant (also known as RAD1901)
Target Population Patients with ER+/HER2- advanced or metastatic breast cancer
Mechanism of Action Selective Estrogen Receptor Degrader (SERD)
Administration Oral, typically 300-400 mg daily
Key Clinical Trials ELCIN, ELIPSE, ELONA, PREMIERE
Combination Studies With abemaciclib, onapristone, and triptorelin
Special Populations Patients with brain metastases, premenopausal women
Primary Outcomes Progression-free survival, overall response rate, safety profile
Secondary Outcomes Duration of response, clinical benefit rate, overall survival
Potential Advantages Efficacy in ESR1-mutated tumors, activity in brain metastases

FAQ

  • What is Elacestrant? Elacestrant is an oral medication being studied for the treatment of advanced breast cancer. It is specifically designed to target estrogen receptor-positive (ER+) and HER2-negative breast cancers.
  • How does Elacestrant work? Elacestrant works as a selective estrogen receptor degrader (SERD). It targets and breaks down estrogen receptors in cancer cells, potentially slowing or stopping the growth of hormone-sensitive breast cancers.
  • What types of patients are being studied in Elacestrant clinical trials? Clinical trials are focusing on patients with advanced or metastatic ER+/HER2- breast cancer, including those who have progressed on prior endocrine therapies. Some studies are also looking at patients with brain metastases or specific genetic mutations like ESR1.
  • Is Elacestrant being studied alone or in combination with other drugs? Both. Some trials are studying Elacestrant as a single agent, while others are investigating its use in combination with other drugs such as abemaciclib (a CDK4/6 inhibitor) or onapristone (another hormone therapy).
  • What are some of the potential benefits of Elacestrant being studied? Researchers are evaluating Elacestrant's potential to improve progression-free survival, overall response rates, and quality of life for patients with advanced breast cancer. Some studies are also looking at its effectiveness in treating brain metastases, which are difficult to treat with current therapies.

Ongoing Clinical Trials on Elacestrant

  • Phase 1b-2 Study of Elacestrant and Abemaciclib in Patients with Brain Metastases from ER-Positive, HER2-Negative Breast Cancer

    Recruiting

    1 1 1
    Investigated drugs:
    Belgium France Germany Greece Italy Spain

  • Study of elacestrant and exemestane treatment for patients with previously treated hormone receptor-positive, HER2-negative metastatic breast cancer with FES-avid lesions

    Recruiting

    1 1 1
    Investigated drugs:
    Italy

  • Study of elacestrant and ribociclib compared to standard treatment for patients with high-risk ER+/HER2- early breast cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Spain

  • Study of Elacestrant and Ribociclib for Patients with Endocrine-Responsive HER2-Negative Early Breast Cancer

    Recruiting

    1 1 1
    Investigated drugs:
    Austria Germany

  • Study Comparing Elacestrant and Standard Endocrine Therapy for Patients with Early Breast Cancer at High Risk of Recurrence

    Recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +9

  • Study on Elacestrant and Everolimus for Patients with Advanced ER+/HER2- Breast Cancer Resistant to Endocrine Therapy and CDK4/6 Inhibitors

    Recruiting

    1 1 1
    Investigated drugs:
    Austria Czechia France Germany Greece Italy +1

  • Study on the Safety and Effects of Vosilasarm Alone and in Combination for Patients with Relapsed Advanced or Metastatic Breast Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Elacestrant for Treating ER+/HER2- Breast Cancer in Patients with ctDNA Relapse

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Cyprus France Germany Greece Ireland +5

  • Personalizing treatment for patients with HR-positive, HER2-negative metastatic breast cancer using fulvestrant, elacestrant, capivasertib, capecitabine, or a drug combination.

    Not yet recruiting

    1 1 1
    Investigated drugs:
    Italy

  • Study on the Effects of Samuraciclib and Elacestrant for Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

Glossary

  • Estrogen Receptor-positive (ER+): A type of breast cancer that has receptors for estrogen, meaning the cancer cells grow in response to this hormone.
  • HER2-negative: Breast cancer cells that do not have high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes cancer cell growth.
  • Metastatic Breast Cancer: Cancer that has spread from the breast to other parts of the body, such as the bones, liver, lungs, or brain.
  • Progression-free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • Clinical Benefit Rate (CBR): The percentage of patients who have a complete response, partial response, or stable disease for a certain period of time.
  • CDK4/6 Inhibitor: A type of drug that blocks specific enzymes involved in cell division, potentially slowing the growth of cancer cells.
  • ESR1 Mutation: A genetic change in the estrogen receptor gene that can make breast cancers resistant to some hormone therapies.
  • Brain Metastases: Cancer that has spread from its original site to the brain.
  • Window of Opportunity Study: A type of clinical trial where a treatment is given for a short time before surgery to study its effects on cancer cells.

References

  1. https://clinicaltrials.eu/trial/phase-1b-2-study-of-elacestrant-and-abemaciclib-in-patients-with-brain-metastases-from-er-positive-her2-negative-breast-cancer/
  2. https://clinicaltrials.gov/study/NCT02338349
  3. https://clinicaltrials.eu/trial/study-of-elacestrant-for-patients-with-estrogen-receptor-positive-her2-negative-metastatic-breast-cancer-who-have-not-used-cdk4-6-inhibitors/
  4. https://clinicaltrials.gov/study/NCT06544577
  5. https://clinicaltrials.gov/study/NCT04797728
  6. https://clinicaltrials.gov/study/NCT06126575
  7. https://clinicaltrials.gov/study/NCT05618613
  8. https://clinicaltrials.gov/study/NCT05982093
  9. https://clinicaltrials.gov/study/NCT06638307